Disc DiseaseNCT01499641
Epidural Steroid Following Discectomy for Herniated Disc Reduces Morbidity
A study testing Methylprednisolone in people with Disc Disease, run by Northern Orthopaedic Division, Denmark at 3 sites in Denmark.
Trial summary
Focus of this study is evaluation of the outcome, neurologic impairment and safety of epidural steroide following lumbar discectomy for herniated disc disease. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Disc Disease
- What is being tested?
- Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesDenmark
- Study dates
- May 2001to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary lumbar herniated disc disease who had received and performed standardized conservative treatment program with intensive exercises
- Patients more than 18 years old
Who cannot join
- Patients with central or lateral spinal stenosis due to spondylosis or disc degeneration who needed bilateral decompression, laminectomy or fusion
- Patients with cauda equina syndrome who needed acute operative treatment
- Lack of informed consent and inability to read and understand Danish
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Orthopaedic Surgery Research Unit, Aalborg University Hospital
Aalborg, 9000
Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet
Copenhagen
Department of Orthopaedic Surgery, Vejle and Give Hospital
Vejle
About this study
Official title: Epidural Steroid Following Discectomy for Herniated Lumbar Disc Reduces Neurological Impairment and Enhances Recovery. A Randomized Study With Two-year Follow-up
Focus of this study is evaluation of the outcome, neurologic impairment and safety of epidural steroide following lumbar discectomy for herniated disc disease.
Read the detailed description
Methylprednisolone might enhance recovery after discectomy for herniated disc disease without apparent side effect.
Convalescence after discectomy for herniated disc disease is dependent on pain and the inflammatory response. In arthroscopic and abdominal surgery steroids reduce the inflammatory response and enhance recovery.
200 patients with herniated disc disease are randomly allocated to receive epidural methylprednisolone 40 mg or none.
- Conditions
- Disc Disease
- Being tested
- Methylprednisolone
- Keywords
- discectomy, methylprednisolone, randomized control trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural methylprednisolone 40 mg or none
| Study group | Role | What they receive |
|---|---|---|
| Epidural steroid | Active comparator | 1.0 mL methylprednisolone acetate 40 mg/mL instilled at the decompressed nerve root Receives: Drug: Methylprednisolone |
| None epidural steroid | Experimental | Not described Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms and signs of neurologic impairment and rate of operation during a 2-year follow-up.
Measured: 2 years
Secondary outcomes (1)
Hospital stay, back and leg pain and reflex deficit.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startMay 2001
- Primary completionAug 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sten Rasmussen, M.D.Sci., Study chair, Orthopaedic Research Unit, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499641
- Sponsor's protocol ID
- ON-07-011-RAS
- Status last verified
- Sep 2014
- First submitted
- 13 Dec 2011
- Last updated
- 15 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Steroid Following Discectomy for Herniated Lumbar Disc Reduces Neurological Impairment and Enhances Recovery. A Randomized Study With Two-year Follow-up
- ClinicalTrials.gov ID
- NCT01499641
- Acronym / sponsor ID
- ON-07-011-RAS
- Conditions
- Disc Disease
- Keywords
- discectomy, methylprednisolone, randomized control trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- May 2001
- Primary completion
- Aug 2003 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Focus of this study is evaluation of the outcome, neurologic impairment and safety of epidural steroide following lumbar discectomy for herniated disc disease.
Detailed description
Methylprednisolone might enhance recovery after discectomy for herniated disc disease without apparent side effect.
Convalescence after discectomy for herniated disc disease is dependent on pain and the inflammatory response. In arthroscopic and abdominal surgery steroids reduce the inflammatory response and enhance recovery.
200 patients with herniated disc disease are randomly allocated to receive epidural methylprednisolone 40 mg or none.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural steroid | Active comparator | Drug: Methylprednisolone1.0 mL methylprednisolone acetate 40 mg/mL instilled at the decompressed nerve root |
| None epidural steroid | Experimental | Drug: Methylprednisolone |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with primary lumbar herniated disc disease who had received and performed standardized conservative treatment program with intensive exercises
- Patients more than 18 years old
Key exclusion criteria (3 listed)
- Patients with central or lateral spinal stenosis due to spondylosis or disc degeneration who needed bilateral decompression, laminectomy or fusion
- Patients with cauda equina syndrome who needed acute operative treatment
- Lack of informed consent and inability to read and understand Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisoloneEpidural methylprednisolone 40 mg or none | Drug | Epidural steroid, None epidural steroid |
Primary outcome
Symptoms and signs of neurologic impairment and rate of operation during a 2-year follow-up.
Time frame: 2 years
1 secondary outcome
Hospital stay, back and leg pain and reflex deficit.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sten Rasmussen, M.D.Sci. study chair
Orthopaedic Research Unit, Aalborg University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylprednisolone in people with Disc Disease, run by Northern Orthopaedic Division, Denmark at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms and signs of neurologic impairment and rate of operation during a 2-year follow-up. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2014.